Design Development and Characterisation of Tramadol Hydrochloride Loaded Transethosomal Gel Formulation for Effective Pain Management

Introduction: The purpose of the present study was to design develop and characterize the tramadol hydrochloride loaded transethosomal gel formulation for effective pain management. Materials and Methods: The transethosomes were prepared by simple cold method. Total 12 formulations were prepared using different concentrations of phospholipid (Soya lecithin and L-α Phosphatidylcholine from egg yolk) and edge activator (Span 20 and Cremophor EL 35).The developed transethosomes were characterized for FTIR, drug content, EE, particle size, zeta potential, TEM, in vitro drug release and release kinetics. The optimised formulation was selected for preparation of transethosomal gel. The formulated gel was estimated for viscosity, drug content, EE and stability study for 28 days. Results and Discussion: The zeta potential of best formulation was -22mV, the particle size was at the range of 149.34 nm to 278 nm. Span 20 formulations exhibit a faster drug release (91.91to 95.7%) than the Cremophor formulations, whose release exhibits an extended pattern (78.96% to 79.34%) at the end of 8th hr. Optimised formulation follows first order kinetics and its R2 value is 0.991. Conclusion: The study supports the development of optimised transethosome formulation into a topical gel using carbopol 934 as gelling agent. The viscosity of the gel formulation was 30168 cps. The drug content and EE was found to be 91.52% and 79.37% respectively. Stability studies prove that there is very less change in the EE, hence the formulation was found to be stable.